FDA Inspection
Rehabtronics Inc.Rehabtronics Inc. – FDA Inspection, Aug 8, 2013
Record Details
This FDA Inspection record concerns Rehabtronics Inc., with an inspection on August 8, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rehabtronics Inc.
- Inspection Date
- August 8, 2013
- Product Type
- Devices
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ID · ac24260f-647e-4dac-b239-f6c6dca4a638
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 846373
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Rehabtronics Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 28, 2018 | Not classified | Office of Inspections and Investigations | |
| February 26, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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